Fibro-Vein 0.2% w/v Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium tetradecyl sulfate

Available from:

STD Pharmaceutical Products Ltd

ATC code:

C05BB; C05BB04

INN (International Name):

Sodium tetradecyl sulfate

Dosage:

0.2 percent weight/volume

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Sclerosing agents for local injection; sodium tetradecyl sulfate

Authorization status:

Marketed

Authorization date:

2001-05-04

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
FIBRO-VEIN 0.2% W/V, 0.5% W/V, 1% W/V AND 3% W/V
SOLUTION FOR INJECTION
Sodium tetradecyl sulphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN
THIS INJECTION.

Keep this leaflet. You may need to read it again
while you are receiving your treatment.

If you have any further questions, please ask your
doctor or pharmacist.

This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.

If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Fibro-Vein Injection is and what it is used for
2.
Before you are given Fibro-Vein Injection
3.
Your treatment with Fibro-Vein Injection
4.
Possible side effects
5.
How to store Fibro-Vein Injection
6.
Further information
1.
WHAT FIBRO-VEIN INJECTION IS AND WHAT IT IS
USED FOR
The name of your medicine is Fibro-Vein Injection,
which contains the active ingredient sodium tetradecyl
sulphate.
This injection belongs to a group of medicines called
sclerosants. Sclerosants are chemical agents, when
injected into the affected vein causes the lining of the
vein walls to swell and the walls stick together. This
stops the flow of blood and the vein turns into scar
tissue. In a few weeks, the vein should fade.
Different strengths of Fibro-Vein Injection are used in
the treatment of varicose veins, minor venules and
spider veins.
2.
BEFORE YOU TAKE FIBRO-VEIN INJECTION
YOU SHOULD NOT TAKE FIBRO-VEIN INJECTION IF YOU:

are allergic (hypersensitive) to sodium tetradecyl
sulphate or to any of the other ingredients in
Fibro-Vein Injection (see section 6, Further
information)

cannot walk due to any reason

have severe inflammation of veins in the
legs(acute phlebitis)

have blood clots in your veins (thrombosis)

have twisted veins (varicose veins) caused by
pelvic or abdominal tumours

are significantly overweight

have any ki

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fibro-Vein 0.2% w/v Solution for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains sodium tetradecyl sulfate 0.2% w/v (equivalent to 2 mg/ml).
Excipients: Contains benzyl alcohol 20 mg/ml, sodium 2.43 mg/ml and
potassium 0.29 mg/ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of minor venules and spider veins (venous flares) by
injection sclerotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION
The smallest needles should be used to perform the injection which
should be made slowly so that the blood content of
these veins is expelled. In the treatment of spider veins an air block
technique may be used.
RECOMMENDED DOSES AND DOSAGE SCHEDULES
_Adults_
0.25 to 1.0ml of 0.2% fibro-vein injected intravenously at a maximum
of 10 sites (maximum 10ml).
_Children_
Not recommended in children.
_Elderly_
As for adults.
4.3 CONTRAINDICATIONS
1.
Allergy to sodium tetradecyl sulfate or to any component of the
preparation.
2.
Patients unable to walk due to any cause.
3.
Patients currently taking oral contraceptives.
4.
Significant obesity.
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5.
Acute superficial thromb